Enhancing Alcohol Treatment Engagement in ALD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Alcohol treatment engagement
研究概览
简要总结
The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.
详细描述
Eligible participants will be randomized to stage 1 of treatment which consists of a previously pilot-tested behavioral application (app), the ENGAGE-ALD app, consisting of a knowledge improvement module and a preference-sensitive treatment matching module. Those who do not engage in AUD treatment after randomization ('non-responders') will be re-randomized at 3-months and continue on this in stage two if considered a responder (met treatment engagement). Participants that were not considered to have met "treatment engagement" will be re-randomized at 3-months to a Treatment Facilitation bundle consisting of a barriers to treatment survey followed by a health coaching session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to comply with all study procedures and availability for the duration of the study
- •Willing and able to provide informed consent
- •Enrolled at University of Michigan (UM) hepatology clinics or inpatients at UM Hospitals
- •Documented diagnosis of alcohol-related liver disease (ALD) (per protocol)
- •Recent alcohol use of any amount within the past 6 months as assessed by either patient interview, medical chart review, or positive alcohol biomarker (e.g. blood alcohol level, urinary ethyl glucuronide, urinary ethyl sulfate, or phosphatidylethanol) in the medical record.
- •No alcohol use treatment within the past 1 month including, but not limited to:
- •Any professionally lead therapy with a mental health counselor (such as, one-on-one therapy, group therapy, couples or family therapy) with a primary aim of alcohol abstinence or reduction in alcohol use.
- •Community-based alcohol recovery groups (such as, Alcoholics Anonymous, SMART Recovery, Celebrate Recovery, Refuge Recovery)
- •Community-based church support groups primarily focused on alcohol abstinence or reduction in use.
- •Residential (inpatient) alcohol treatment
- •Intensive outpatient programs
- •Any telehealth version of the above options
- •Access to a Smartphone or computer for purposes of follow-up. Those who do not have a Smartphone will be provided one along with a calling/data plan at no cost to subject by the study team for the duration of the research stud.
- •Ability to speak and comprehend English
排除标准
- •Unable to provide voluntary informed consent for any reason
- •Substantially cognitively impaired as evidenced by Westhaven grade 2 or higher hepatic encephalopathy or a score >=10 on the Short Blessed Test for cognitive impairment.
- •Unable to read or understand English
- •Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation
- •Is enrolled in the multidisciplinary ALD clinic at Michigan Medicine
- •Any other medical condition or circumstance that precludes safe and meaningful participation in the study
- •History of nonadherence to previous clinical or research studies
研究组 & 干预措施
Enhanced usual care (EUC)
Eligible participants randomized will be given this for stage 1 of treatment (three months) and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.
干预措施: Enhanced Usual Care (Behavioral)
ENGAGE-ALD application (app)
Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.
干预措施: ENGAGE-ALD Application (APP) (Behavioral)
ENGAGE-ALD app then Treatment Facilitation Bundle
Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).
干预措施: ENGAGE-ALD Application (APP) (Behavioral)
ENGAGE-ALD app then Treatment Facilitation Bundle
Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).
干预措施: Treatment Facilitation bundle (Behavioral)
Enhanced usual care then Treatment Facilitation Bundle
Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).
干预措施: Treatment Facilitation bundle (Behavioral)
Enhanced usual care then Treatment Facilitation Bundle
Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).
干预措施: Enhanced Usual Care (Behavioral)
ENGAGE-ALD app then Enhanced usual care
Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment. Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized to the EUC arm stage 2 (three months).
干预措施: ENGAGE-ALD Application (APP) (Behavioral)
Enhanced usual care then Enhanced usual care
Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be rerandomized to the Enhanced usual care arm stage 2 (three months).
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Alcohol treatment engagement
时间窗: Baseline and six months
Measured using self-report and defined as any single session (in-person or virtual) of the following: * Professional mental health counselor led one-on-one therapy, group therapy, couples, or family therapy with a primary aim of alcohol abstinence or reduction in alcohol use. * Community-based alcohol recovery groups (such as Alcoholics Anonymous, Self-Management and Recovery Training (SMART) Recovery, Celebrate Recovery, Refuge Recovery) * Community-based church support groups primarily focused on alcohol abstinence or reduction in use * Residential (inpatient) alcohol treatment * Intensive outpatient programs * Any telehealth version of the above options
次要结局
- Percent heavy drinking days (PHDD)(Six months)
- Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants(Baseline and six months)
- Change in Liver health based on liver laboratory values (total bilirubin) for all participants(Baseline and six months)
- Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method(Baseline and six months)
- Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis(Baseline and six months)
研究者
Jessica Mellinger
Principal Investigator
Henry Ford Health System